Z-0523-2014Class II

outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx...

Name: Z-0523-2014 outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx...
Creator: Biomet, Inc.
Published: 2013-11-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-11-26 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single... on 2013-11-26. FDA classified it as Class II and gives the reason as "Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0523-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2013-12-17
Terminated: 2015-07-07
Recalling firm: Zimmer GmbH
Product: outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.
Product code: HTD Forceps
Reason for recall: Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Biomet sent an Urgent Medical Device Recall Notice dated November 26, 2013, to all affected customers. The notice identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm by FAX 574-372-1683. Customers with questions were instructed to call 574-372-1570. For questions regarding this recall call 574-372-1570.
Quantity in commerce: 21
Distribution: Nationwide Distribution including MI, IA, IL, IN, and TN.
Product codes and lots: Lot 055450

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0523-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0523-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

Product code HTD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)